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EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
This study has been completed.
Study NCT00049231   Information provided by National Cancer Institute (NCI)
First Received: November 12, 2002   Last Updated: February 6, 2009   History of Changes

November 12, 2002
February 6, 2009
June 2003
 
 
 
Complete list of historical versions of study NCT00049231 on ClinicalTrials.gov Archive Site
 
 
 
EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer

RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 may be effective in measuring oxygen in tumor tissue and helping to predict the effectiveness of anticancer therapy.

PURPOSE: Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in patients who have stage IIB, stage IIIB, or stage IVA cervical cancer.

OBJECTIVES:

  • Determine the relationship between the level of EF5 binding and pretreatment hemoglobin level, tumor size, and stage of disease in patients with stage IIB, IIIB, or IVA cervical cancer.
  • Determine whether pretreatment tumor hypoxia (measured by EF5 binding) is associated with overall survival, progression-free interval, and local control in these patients.
  • Determine the relationship between EF5 binding and CD-31 labeling (tumor vasculature) and Ki-67 labeling (cellular proliferation) in these patients.

OUTLINE: This is a multicenter study.

Patients receive EF5 IV over 1-2.5 hours on day 1. Tumor hypoxia is measured using immunohistochemical techniques. Biopsies are collected 1-2 days later. Blood is collected before EF5 is administered and again at the time of surgery.

Patients are followed approximately 1 month after surgery.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 3 years.

 
Interventional
Diagnostic, Open Label
Cervical Cancer
  • Drug: EF5
  • Other: immunohistochemistry staining method
  • Procedure: biopsy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix

    • Stage IIB, IIIB, or IVA
    • Primary disease
  • No prior treatment
  • Must be enrolled on GOG-0191 protocol

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • Hemoglobin less than 13 g/dL

Renal

  • Creatinine no greater than 2 mg/dL

Cardiovascular

  • No cardiac disease that would preclude safe administration of necessary fluid volumes

Pulmonary

  • No chronic pulmonary disease that would preclude safe administration of necessary fluid volumes

Other

  • No history of grade 3 or 4 peripheral neuropathy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must weigh no more than 180 kg

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049231
 
CDR0000258053, GOG-8002
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon) Edmond Odette Cancer Centre at Sunnybrook
National Cancer Institute (NCI)
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP